Treatment of the Biceps With Concomitant Supraspinatus Tears

NCT ID: NCT05660031

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2026-06-01

Brief Summary

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.

Detailed Description

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology.Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.

Conditions

Supraspinatus Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Leaving LHB Intact

The long head of the biceps (LHB) will be left intact.

Group Type: NO_INTERVENTION

No interventions assigned to this group

LHB tenotomy

The long head of the biceps (LHB) will be cut at its origin.

Group Type: EXPERIMENTAL

LHB Tenotomy

Intervention Type: PROCEDURE

Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors

LHB Tenodesis

The long head of the biceps (LHB) will be cut at its origin and reattached.

Group Type: EXPERIMENTAL

LHB Tenodesis

Intervention Type: PROCEDURE

"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.

Interventions

LHB Tenotomy

Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors

Intervention Type: PROCEDURE

LHB Tenodesis

"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
• Full thickness tear of the supraspinatus tendon
• Intact subscapularis tendon
• Primary rotator cuff repair
• Age 50-80

Exclusion Criteria

• Previous full thickness biceps tear
• Infection and neuropathic joints
• Known or suspected non-compliance, drug or alcohol abuse
• Patients incapable of judgement or under tutelage
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Patient declines to participate in study

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

La Tour Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alexandre Lädermann

Orthopaedic Surgeon FMH, Shoulder and Elbow Surgery Traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Lädermann, MD

Role: PRINCIPAL_INVESTIGATOR

La Tour Hospital

Locations

Sports Medicine and Shoulder Surgery, University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Group 23 Sports Medicine

Calgary, Alberta, Canada

Site Status: RECRUITING

la Tour hospital

Meyrin, Canton of Geneva, Switzerland

Site Status: RECRUITING

Countries

United States; Canada; Switzerland

Central Contacts

Alexandre Lädermann, MD

Role: CONTACT

alexandre.laedermann@gmail.com

+41 22 71 975 55

Facility Contacts

Asheesh Bedi, MD

Role: primary

asheesh.bedi@gmail.com

Patrick Denard, MD

Role: primary

pjdenard@gmail.com

Ian K Lo, MD

Role: primary

ikylo@ucalgary.ca

Alexandre Lädermann, MD

Role: primary

alexandre.laedermann@gmail.com

+41 22 719 75 55

Other Identifiers

2021-00066

Identifier Type: -

Identifier Source: org_study_id